Osteoporosis Clinical Process Framework Steven Levenson, MD, CMD 1

Normal and Osteoporotic Bone 2

The Clinical Process Framework Project      Now over a decade Started with “Green Bill” Coordinated effort between survey agency, providers, others Resulting clinical process frameworks  Based on information in AMDA CPGs and other references and resources A precursor to “Advancing Excellence” process frameworks 3

Care Process Steps     Assessment / Problem recognition Diagnosis / Cause identification Management / Treatment Monitoring 4

OSTEOPOROSIS Clinical Process Framework    Care process step Expectations Rationale 5

ASSESSMENT / PROBLEM RECOGNITION 6

Osteoporosis: Assessment / Problem Recognition   Step 1  Did staff and physician seek and document any history of osteoporosis? Expectations  On admission and thereafter as indicated, staff and practitioner seek and document factors associated with, or presenting risk for, osteoporosis 7

Step 1 Rationale  History may include      Loss of height History of fractures (often with minimal or no trauma) Chronic back pain due to vertebral compression fractures Positive X-Ray finding of thinning of bone [osteopenia] Positive bone density study (DEXA scan) 8

Osteoporosis: Assessment / Problem Recognition   Step 2  Did staff identify individuals with (or risk for) osteoporosis and its complications?

Expectations  Staff and practitioner   Identify individuals with loss of bone mass and complications related to decreased bone mass Identify and document risk factors for developing osteoporosis or for worsening of existing bone loss 9

Step 2 Rationale  Risk factors may be  Modifiable, for example      Inadequate calcium and vitamin D intake Excess alcohol intake Smoking Medications that impair bone metabolism Nonmodifiable, for example     Age Female gender Caucasian or Asian race Small body frame 10

Step 2 Rationale  Various medications can increase risk of osteoporosis, for example  Anticonvulsants, proton pump inhibitors (PPIs), heparin, thyroid hormone replacement, glucocorticoids, Vitamin A 11

Osteoporosis In Men: Significant Risk Factors     Age (>70 years) Low body weight (body mass index <20 to 25 kg/m2 or lower) Weight loss (>10% compared with usual young or adult weight or weight loss in recent years) Physical inactivity (no regular physical activity; e.g., walking, climbing stairs, housework, gardening 12

Osteoporosis In Men: Significant Risk Factors   Use of oral corticosteroids Previous fragility fracture  Reference: Qaseem A, Snow V, Shekelle P, Hopkins Are, Forciea MA, Owens DK; Clinical Efficacy Assessment Subcommittee of the American College of Physicians. Screening for osteoporosis in men: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2008 May 6;148(9):680-4 13

Step 2 Rationale   May be benefits to addressing modifiable risk factors Risk factors for complications include  Fall history, gait and balance disturbances, medication adverse consequences, Vitamin D deficiency 14

Definitions    Osteoporosis (women)  BMD that is 2.5 SD or more below the mean for women at age 30 Osteopenia  BMD that is 1-2.5 SD below the average, for young, healthy white women. To date, similar criteria for osteoporosis in men 15

Standard Deviations  Source: http://en.wikipedia.org/wiki/Standard_deviation 16

Osteoporotic Fracture Risks Over Time 17

Hip Fracture Risks in Swedish Women  Source: www.medicographia.com

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DEXA Scanner 19

BMD Scoring   T score  Compares bone density with that of healthy young women Z score  Compares bone density with that of other people of age, gender, and race 20

BMD Scanning  Also called dual-energy x-ray absorptiometry (DXA) or bone densitometry   An enhanced form of x-ray technology used to measure bone loss Current standard for measuring bone mineral density (BMD) 21

BMD Scanning   DXA most often done on lower spine and hips CT scan with special software can also be used 22

FRAX Scoring 23

FRAX     Computer-based screening tool that predicts the risk of developing osteoporosis Scoring system utilizing BMD results Developed by World Health Organization, WHO Can help identify individuals who should have additional testing and treatment, also depending on prognosis 24

Osteoporosis: Assessment / Problem Recognition   Step 3  Did staff and practitioner identify complications of osteoporosis?

Expectations  Staff and practitioner collaborate to identify complications  Examples: impaired mobility, pain at fracture sites, deformities, deconditioning, neurological complications, psychological issues  May include in care plan document 25

DIAGNOSIS / CAUSE IDENTIFICATION  Step 4  Did practitioner and staff seek causes of osteoporosis or indicate why causes could not or should not be sought?

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DIAGNOSIS / CAUSE IDENTIFICATION 27

DIAGNOSIS / CAUSE IDENTIFICATION  Expectations    Identify individuals who may benefit from additional workup Identify any additional diagnostic workup indicated to help define presence, severity, and/or causes of decreased bone mass Collaborate to document rationale for not screening or attempting to confirm suspected diagnosis of bone mass loss 28

Step 4 Rationale: Common Causes        Some medications (e.g., Dilantin, steroids) Hyperthyroidism Hyperparathyroidism Chronic renal failure Malabsorption syndromes Multiple myeloma Vitamin D deficiency 29

Step 4 Rationale: Possible Testing  Additional screening or diagnostic testing may not be needed if clinical evidence has already suggested or confirmed condition  For example, positive X-Ray showing bone thinning, a high score on a risk assessment tool, or history of vertebral compression fractures 30

Step 4 Rationale: Possible Testing  In absence of existing confirmation of diagnosis, presence of more advanced bone loss or significant complications may warrant screening or diagnostic testing  In absence of contraindications (e.g., terminal condition or advanced medical illness 31

Step 4 Rationale: Possible Testing  Depending on the situation, additional tests may include     pDEXA scan for bone density screening Serum calcium and Vitamin D levels TSH (hyperthyroidism) Renal function tests (chronic renal failure) 32

TREATMENT / PROBLEM MANAGEMENT 33

Step 5   Did facility identify and initiate appropriate general and specific interventions?

Expectations  Staff and practitioner institute relevant general and cause-specific interventions, or provide clinically pertinent reason for not doing so 34

Step 5 Rationale  Some individuals may benefit from risk reduction and cause management  Generic and cause-specific  Generic: those applicable to all at-risk individuals 35

Generic Interventions   Calcium (total 1200-1500 mg/day from all sources) Vitamin D (total 800-1000 IU/day from all sources) supplementation  These may reduce additional bone loss but will not significantly improve existing bone loss 36

Generic Interventions   Exercise—especially weight bearing activity—may reduce bone loss Fall prevention strategies may help reduce falls and subsequent fall-related complications of decreased bone mass 37

Vitamin D      Vitamin D appears to reduce fall risk  In addition to effects on bone density Serum Vitamin D levels should be at least 24 ng/ml to reduce fall risk Effect occurs after short duration of use Toxicity is possible although rare Watch for hypercalcemia  May bring out hyperparathyroidism 38

Step 6   Did staff and practitioner consider possible individuals for whom additional treatment may be indicated? Expectations  Practitioner and staff identify individuals who can benefit from additional treatments 39

Step 6 Rationale   Several options for medications to try to reverse bone loss  Bisphosphonates    Calcitonin Parathyroid hormone Hormone replacement therapy or estrogen receptor modulators  Osteoclast inhibitors All medications for osteoporosis treatment should be prescribed and given consistent with manufacturers’ specifications and pertinent warnings related to use  Including adverse consequences and drug interactions 40

Step 6 Rationale   Some individuals may not be able to tolerate side effects or comply with manufacturer’s specifications for taking these medications Do vertebroplasty and kyphoplasty help to stabilize vertebral compression fractures?

 NEJM 2009; 361:557-568 - May be no more beneficial than medical pain management 41

Step 7   Did staff and practitioner address complications and related risk factors? Expectations   Staff institute relevant fall prevention strategies Staff and practitioner identify and address symptoms such as pain related to osteoporosis or its complications 42

Step 7  Expectations  Staff and practitioner evaluate patient’s current medication regimen and address medications that  Are identified or suspected as affecting bone density  May predispose to complications from osteoporosis; e.g., increase fall risk and thereby may increase risk of fracture 43

Step 7 Rationale   Measures to try to prevent falls and related injury may prevent injury related complications due to osteoporosis No interventions can prevent all falls  Sometimes necessary to focus on trying to minimize severity of complications, to extent possible 44

MONITORING 45

Step 8   Did practitioner and staff follow up on individuals with osteoporosis?

Expectations  Practitioner and staff monitor progress of the condition and the individual’s response to any interventions  Based on criteria that are relevant to the individual resident 46

Step 8 Rationale   Sometimes difficult to identify specific long-term benefits of osteoporosis treatment in individuals Examples of monitoring may include— as clinically appropriate—functional capacity, degree of pain, and progression, stabilization, or reduction of bone mass loss 47

Step 9   Did staff and physician consider justification for continuing current approaches? Expectations  Staff and practitioner review information that can help identify the rationale for continuing treatment 48

Step 9 Rationale  Various circumstances may affect decisions about continuing or modifying treatments     Prognosis Responsiveness to treatment Possibility for changing to a less obtrusive or lower-risk intervention Resident satisfaction with the benefits of— or concern about complications related to—treatment 49

Step 9 Rationale  Reduced compliance with osteoporosis medications is common  Mostly due to adverse consequences 50

Step 10   Did staff and practitioner monitor for, and address, complications of osteoporosis and of treatments for osteoporosis? Expectations  Staff and practitioner monitor for, and manage, complications of osteoporosis and of various treatments for osteoporosis 51

Step 10 Rationale  Side effects of osteoporosis medications may include     Symptoms of Vitamin D or calcium excess Gastrointestinal irritation including erosive esophagitis or gastritis (bisphosphonates) Bone pain Others that are specific for the medication that is given 52

Osteoporosis 53